The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Tdx Digoxin.
| Device ID | K820154 |
| 510k Number | K820154 |
| Device Name: | TDX DIGOXIN |
| Classification | Radioimmunoassay, Digoxin (125-i) |
| Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
| Product Code | LCS |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-19 |
| Decision Date | 1982-02-05 |